Progress of Phase I programme with oral iclaprim
The completed Phase I study was designed as a double-blind, placebo-controlled, dose escalation trial. A total of 32 subjects participated in the study (16 males and 16 females). Safety and tolerability were evaluated after administration of supra-therapeutic doses aimed at determining the maximal tolerated dose.
No serious adverse events were reported. Only after administering five-fold the targeted therapeutic dose, the number of adverse events showed a significant increase relative to placebo and this dose was then defined as the maximal tolerated dose in humans. All reported adverse events were mild-to-moderate in nature and mainly concerned vomiting and nausea. As in previous clinical trials with iclaprim, ECG monitoring was conducted. No clinically relevant increases in the QTc interval were observed at any of the investigated doses.
A further Phase I study, investigating the safety and tolerability of multiple administration of supra-therapeutic doses of oral iclaprim is currently ongoing. In addition, slow-release administration at supra-therapeutic doses is being investigated.
"Rolling" NDA for intravenous iclaprim in cSSSI; electronic submission of first modules due before year-end 2007
Arpida has made very good progress in compiling the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI). The NDA forms the basis for the U.S. Food and Drug Administration (FDA) for its evaluation of a drug candidate's eligibility for marketing approval.
Arpida has agreed with the U.S. FDA to file the NDA in a rolling
process. Using a 'rolling NDA' allows the different modules within the
overall package to be filed individually. Arpida has further agreed to file
the NDA in an electronic format. Test
|SOURCE Arpida Ltd|
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